Global consequences of the US FDA's accelerated approval of cancer drugs

The accelerated approval system is a fast-track drug approval pathway created by the US Food and Drug Administration (FDA) in 1992 in response to the HIV-AIDS crisis to allow expedited access to life-saving drugs and fulfil an unmet medical need. Nowadays, this pathway is most commonly used for cancer drug approval.1 In theory, the accelerated approval pathway strikes a balance between early access to therapies and the need for robust evidence generation. This pathway allows drugs to be approved early on the basis of improvement in surrogate outcomes that are reasonably likely to translate to clinical benefit.